NCT00431548

Brief Summary

Ocular lesions, including cotton wool spots and retinal hemorrhage, are a common feature of HIV infection and acquired immunodeficiency syndrome (AIDS). The aetiology of these apparently vasoocclusive phenomena in HIV related retinopathy is not well understood. Several hypotheses including infectious damage of the retinal vasculature and altered retinal hemodynamics have been postulated. The latter would be compatible with the theory that the retina of HIV patients is hypoxic. However, direct measurement of oxygen tension in the retina is not possible and indirect methods have to be employed. The study objective was to investigate the reactivity in retinal blood flow to 100% oxygen breathing in patients with HIV.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
Last Updated

February 6, 2007

Status Verified

February 1, 2007

First QC Date

February 5, 2007

Last Update Submit

February 5, 2007

Conditions

HIV InfectionsRetinaOcular Physiology

Outcome Measures

Primary Outcomes (1)

  • Reactivity in retinal blood flow during 100% O2 breathing expressed as percent change

Interventions

100% O2DRUG

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Group 1 (Patients with HIV)
  • Aged between 19 and 70 years, male and female
  • HIV positive patients without HIV-related retinopathy with a CD4+ cell count  500 cells/mm3 stage A2, A3, B2, B3, C2 and C3.
  • Best corrected visual acuity \>= 0.8
  • Ametropy \< 6 dpt
  • Group 2 (Healthy control subjects)
  • Aged between 19 and 70 years
  • Age and sex matched to the subjects in the HIV group (group matched)
  • Matched with regard to the smoking habits in the HIV group
  • Best corrected visual acuity \>= 0.8
  • Ametropy \< 6 dpt

You may not qualify if:

  • Evidence of any other eye disease
  • Diabetes mellitus
  • Systemic hypertension (defined as SBP \> 150 mmHg or DBP \> 90 mmHg)
  • Abuse of illegal drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Hans-Georg Eichler, MD

    Department of Clinical Pharmacology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 6, 2007

Last Updated

February 6, 2007

Record last verified: 2007-02

Locations

AU(1)